Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-10 @ 6:52 PM
Study NCT ID:
NCT05763758
Status:
UNKNOWN
Last Update Posted:
2023-03-23
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thalamocortical functional connectivity', 'timeFrame': 'baseline', 'description': 'functional connectivity between the thalamus and cortex as measured by resting state fMRI'}, {'measure': 'alpha oscillations', 'timeFrame': 'baseline', 'description': 'alpha oscillations as measured by EEG and MEG'}], 'secondaryOutcomes': [{'measure': 'alpha band source', 'timeFrame': 'Baseline', 'description': 'MEG and EEG data will be used to estimate the alpha band source'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EEG, fMRI, thalamus, pain, experimental pain, low back pain'], 'conditions': ['Experimental Pain', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to identify spatiotemporal alterations in thalamocortical circuitry functioning in both healthy subjects and patients with chronic pain, combining multimodal neuroimaging.', 'detailedDescription': 'Investigators will pursue this goal in both experimental and clinical models at two sites (Florida State U/FSU \\& Mass General Hospital/MGH), implementing parallel enrollment of large and diverse samples (140 healthy participants and 60 patients with chronic low back pain/cLBP). Leveraging the fully developed multimodal neuroimaging methodology-simultaneous EEG-fMRI and combined EEG-MEG-fMRI, the investigators will investigate TC dysconnectivity (fMRI) and alpha dysrhythmia (EEG/MEG) during experimental pressure pain and chronic back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects and individuals with chronic low back pain', 'healthyVolunteers': True, 'eligibilityCriteria': "Healthy subjects for both MGH and FSU sites\n\nInclusion Criteria:\n\n1. healthy male and female adults\n2. Between the ages of 18 and 60 years\n3. Meeting the MRI / MEG / EEG screening criteria\n4. Fluent in English; English can be a second language provided that the patients understand all questions used in the assessment measures. This will be asked and judged during the phone screen.\n\nExclusion Criteria:\n\n1. Current or past history of major medical, neurological, or psychiatric illness based on self-report\n2. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)\n3. History of head trauma\n4. Pregnant or lactating\n5. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)\n6. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)\n7. Active substance abuse disorders (based on subject self-report)\n\nSubjects with chronic low back pain (MGH site)\n\nInclusion Criteria:\n\n1. Volunteers 18-60 years of age\n2. Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)\n3. At least 4/10 clinical pain on the 0-10 LBP NRS\n4. Meeting the MRI / MEG / EEG screening criteria\n5. Fluent in English; English can be a second language provided that the patients understand all questions used in the assessment measures. This will be asked and judged during the phone screen.\n\nExclusion Criteria:\n\n1. Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)\n2. Complicated back problems (eg, prior back surgery, medicolegal issues)\n3. The intent to undergo surgery during the time of involvement in the study\n4. Current or past history of major medical, neurological, or psychiatric illness based on self-report\n5. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)\n6. History of head trauma\n7. Pregnant or lactating\n8. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)\n9. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)\n10. Active substance abuse disorders (based on subject self-report)\n11. Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents\n12. Current use of psychotropic medication"}, 'identificationModule': {'nctId': 'NCT05763758', 'briefTitle': 'Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain', 'orgStudyIdInfo': {'id': '2022p003171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control', 'description': 'Healthy participants will undergo multimodal neuroimaging during resting state, no-pain and painful tonic pressure presentation. At FSU, EEG and fMRI will be simultaneously acquired. At MGH, sequential MRI and MEG/EEG will be acquired.', 'interventionNames': ['Other: No intervention']}, {'label': 'Patients with chronic low back pain', 'description': 'Subjects with chronic low back pain (cLBP) patients will undergo multimodal neuroimaging during resting state, no-pain and painful tonic pressure presentation. The study will only be performed at MGH, sequential MRI and MEG/EEG will be acquired.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention involved in this study', 'armGroupLabels': ['Healthy Control', 'Patients with chronic low back pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '323060000', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Wen Li', 'role': 'CONTACT', 'email': 'wenli@psy.fsu.edu', 'phone': '850-645-1409'}], 'facility': 'Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'centralContacts': [{'name': 'Jian Kong', 'role': 'CONTACT', 'email': 'jkong2@mgh.harvard.edu', 'phone': '16179620978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jian Kong', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}